BIOSTATISTICS SHARED RESOURCE ? PROJECT SUMMARY/ABSTRACT The mission of the biostatistics shared resource (BSR) is to serve as a focal point for University of Virginia Cancer Center (UVACC) members to obtain assistance in the design, management and analysis of their studies. The services provided by this resource include: 1) Biostatistical collaboration and consultation in the design of clinical trials, observational studies and laboratory studies. An appropriate statistical design is necessary if the research is to be successful in fulfilling the scientific objectives. 2) Statistical expertise in data analysis. The specific methods employed depend on the randomization or sampling design of the particular project and on the scale (binary, ordered categorical, or continuous) of the outcome variable being investigated. Statistical data analyses are performed using both packaged and special purpose computer programs. 3) Scientific review, quality control, and data and safety study monitoring for clinical trials. Involvement throughout the entire process is important to ensure that valid designs are planned as well as followed. 4) Education; through formal and informal seminars, courses and lectures. Education defines the academic environment for which all members participate. 5) Development of statistical methodology, computer programs and infrastructure necessary for meeting the scientific objectives of specific research studies. Advances in research can require the development of new statistical methodologies to achieve the research goals. The BSR enriches research at the UVACC by providing high quality design and analyses for basic, clinical and translational studies and unique expertise in novel designs in early phase trials. The BSR provides statistical knowledge in all phases of clinical research, including scientific and safety review, data quality, and monitoring of on-going trials. Through its educational efforts, the BSR promotes an understanding of statistical principles that enhances research efforts in the UVACC. We have increased the breadth of our collaborative skills to include new areas of expertise including joint modeling of longitudinal assessments and time-to-event endpoints, analyses to assess synergy in pre-clinical studies, and methods for tumor outgrowth studies while augmenting our core expertise in early phase trial design.